2026 First Batch of Unannounced Inspections: All 40 Companies Cited — Breakdown of 5 High-Frequency Defects in Functional Skincare OEM Factories

On July 22, the National Medical Products Administration (NMPA) Inspection Center released the "Notice on Medical Device Unannounced Inspection Status (2026 No. 1)", publicly citing systemic deficiencies in 40 medical device manufacturers at once — a 100% detection rate, a number striking enough in any industry.

The inspection scope covered multiple provinces including Hunan, Jiangxi, Shandong, Beijing, Zhejiang, Jiangsu, Guangdong, Gansu, and Sichuan, with product types involving medical dressings, dialyzers, balloon catheters, guidewires, stent systems, and testing reagent kits.

Those doing functional skincare OEM work might think, "This has nothing to do with me — I don't make implants." But look closely at the deficiency list: 5 of these problem categories are almost directly related to medical dressings and functional skincare OEM manufacturing.

I. TOP 5 High-Frequency Defects: Detailed Breakdown

Defect 1: Insufficient Competence of Personnel in Key Positions (Most Frequent)

Nearly half of the 40 companies were cited for this issue.

Typical scenario: Inspectors arrive on site and give regulatory tests to the management representative, quality manager, and production manager — they fail.

Specific cases: - The management representative of a Changsha company had only a college diploma, no quality management work experience, and failed the on-site regulatory test - A company's production manager was unfamiliar with the core provisions of the "Good Manufacturing Practice for Medical Devices" and failed the test - One company conducted training only once a year, 3 hours each time, and the 2024 and 2025 assessment papers were identical

Warning for OEM factories: Can your management representative clearly explain the core provisions of the "Good Manufacturing Practice for Medical Devices"? Can your inspectors operate the ethylene oxide residual testing equipment? If inspectors ask 3 questions on-site and you can't answer 2, this deficiency is unavoidable.

Practical recommendations: Conduct regulatory internal training + closed-book testing once per quarter — not just sign-in and take photos. Key training targets: management representative, quality manager, production manager, and inspectors. Training content should align with the latest regulatory version — don't reuse two-year-old test papers.

Defect 2: Equipment Calibration Range Does Not Cover Actual Usage Range (Second Most Frequent)

This issue appeared repeatedly across the 40 companies, with at least 7 having similar problems.

Typical scenarios: - UV irradiance meter has a range of 0-200 mW/cm², but the calibration standard value used was 354 mW/cm² — calibrating without actually calibrating - Digital force gauge calibrated at 60-300 N, but actual usage range is 6-10 N - Sealing machine calibration does not cover actual operating temperatures - UV spectrophotometer only calibrated for the 340-900 nm band, but protein testing requires 215 nm and 225 nm

Warning for OEM factories: For medical dressing OEM work, the calibration certificates of key equipment such as emulsifiers, filling machines, and sterilization chambers must cover your actual process parameters. Many factories take shortcuts by having metrology institutes calibrate to the equipment's full range, regardless of actual usage. If the calibration range doesn't match the usage range, it's equivalent to no calibration in unannounced inspections.

Practical recommendations: Conduct a self-audit of equipment calibration — compare the actual usage parameters (temperature, pressure, time, power) of each key piece of equipment against the calibration points on the certificates. For any gaps, arrange supplementary calibration.

Defect 3: Incomplete and Untraceable Production Records

Typical scenarios: - Key process parameters (temperature, time, speed, etc.) not recorded - Material batch numbers not recorded - Inspection records only state "OK" without original numerical values - Batch production records do not match material management records

One company was cited for: after first-article inspection failed, the production department adjusted parameters, re-produced, and re-inspected until passing — but the failed first-article data was not recorded, no charts were printed, and it "disappeared" from the records, only appearing as "1 unit scrapped."

Warning for OEM factories: Record-keeping issues are a long-standing target in unannounced inspections. Many factories think, "As long as the product passes, the records are good enough." But the current regulatory logic is: untraceable records = untrustworthy products. No matter how good your finished product testing looks, if records don't match up, the entire batch can be deemed non-conforming.

Practical recommendations: ① Batch production records must include actual measured values of all key process parameters, not just the word "qualified"; ② Inspection records must include raw data plus calculation processes; ③ Cross-check material inbound/outbound records against batch production records to ensure the batch number chain is complete.

Defect 4: Insufficient Design and Development Transfer

More than 80% of the 40 companies had design and development-related deficiencies — the most frequently occurring problem category.

Typical cases: - A company's registration certificate listed 18 fill volume specifications, but process validation was only done for 2 specifications; the remaining 16 had no validation or typicality justification - A company's product technical requirements and production process flow didn't match, with inconsistent quality control point descriptions - Design changes didn't go through the review process — suppliers were changed and process parameters were modified, but review records were empty

Warning for OEM factories: In OEM work, the brand owner may give you product specifications with 5 fill volumes and 3 concentrations. Your process validation must cover all specifications — you can't just validate 1-2 typical ones and call it done. Every specification listed on the registration certificate must be supported by validation data on the production line.

Defect 5: Inadequate Supplier Audits

Typical scenarios: - No on-site audits conducted for key suppliers - Incomplete purchasing information — material specifications, models, and quality standards not clearly defined - Key materials not managed as key materials

Warning for OEM factories: OEM factories must have stricter supplier management than brand owners, because you are the production entity. Raw material suppliers, packaging material suppliers, and sterilization service providers must all be included in the approved supplier list, with at least one on-site audit or written review per year. Don't wait until the unannounced inspection arrives to hastily patch together files.

II. OEM Factory Self-Inspection Checklist

Based on the deficiency distribution across the 40 companies, an OEM factory can complete a self-inspection by checking just 5 dimensions:

1. Personnel dimension: Can the management representative, quality manager, and production manager answer core regulatory provisions without notes? Are inspectors familiar with operating procedures for key equipment? Do training records include assessment results?

2. Equipment dimension: Do calibration certificates for key equipment cover actual usage parameters? Is there a maintenance log for equipment? Have newly purchased equipment completed installation qualification and process validation?

3. Records dimension: Do batch production records include actual measured values of all key process parameters? Do inspection records contain raw data? Is the material batch number chain complete and traceable?

4. Design and development dimension: Have all specifications on the registration certificate completed process validation? Did design changes go through the review process? Are change records complete?

5. Supplier dimension: Have key suppliers completed on-site audits? Does purchasing information clearly specify models and quality standards? Is material classification reasonable?

Spend half a day on each of the 5 dimensions, and you can complete the self-inspection in 1-2 days. Identifying and rectifying issues promptly is far better than scrambling when the unannounced inspection arrives.

III. Conclusion

All 40 companies being cited doesn't mean the industry is terrible — it means regulatory standards are rising.

In the past, unannounced inspections might last 2-3 days and check a few key items. Now they go through everything in one pass, with increasingly detailed deficiency classifications and more probing questions about "why you do it this way."

For OEM factories, compliance is not a cost — it's a moat. Factories that can run their systems properly will earn long-term partnerships with brand owners; those that can't will be cited today, suspended for rectification tomorrow, and lose customer orders overnight.

Data sources: NMPA Inspection Center "Notice on Medical Device Unannounced Inspection Status (2026 No. 1)" (released July 22, 2026), and public news reports. Company information in this article is compiled based on the original notice.