# FDA WARNING_LETTER - Superior Glove Works, Ltd. - September 27, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/superior-glove-works-ltd/755b3645-0213-49f9-bb33-be30239c6a9c

> FDA WARNING_LETTER for Superior Glove Works, Ltd. on September 27, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Superior Glove Works, Ltd.
- Inspection Date: 2022-09-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Superior Glove Works, Ltd. on December 16, 2022, following a review of records submitted in response to a Section 704(a)(4) request. The facility, registered as an OTC drug manufacturer until August 25, 2022, produced consumer antiseptic hand rub drug products.

The FDA found significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Key violations include:

1.  **Failure to test component identity (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming raw materials, specifically ethanol API, for impurities like acetaldehyde and methanol. A supplier's Certificate of Analysis (COA) showed acetaldehyde at 205 ppm and total impurities at 2,846 ppm, exceeding acceptable levels (USP limit for acetaldehyde is 10 ppm). This led to a voluntary nationwide recall of one batch of Synergy Hand Sanitizer (HS) Alcohol Antiseptic 80% Topical Solution.

2.  **Failure to test finished drug products (21 CFR 211.165(a)):** The firm did not perform full release testing, including for identity, strength, and impurities, on over 90 shipments of hand sanitizer distributed to the

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Hubert Parsons](https://www.globalkeysolutions.net/people/hubert-parsons/8e8b8a05-a485-4bc6-aa2f-26a580e47f2f)

Company: https://www.globalkeysolutions.net/companies/superior-glove-works-ltd/61dee1aa-5d6a-4ffe-90a2-d03c3de01409

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c