# FDA WARNING_LETTER - Laboratorio Pharma International SRL - September 21, 2021

Source: https://www.keypedia.com/records/warning_letter/laboratorio-pharma-international-srl/52df36ac-3969-42b8-ad4b-272e0ce17c50

> FDA WARNING_LETTER for Laboratorio Pharma International SRL on September 21, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Laboratorio Pharma International SRL
- Inspection Date: 2021-09-21
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Laboratorio Pharma International S. de R.L. (FEI 3012015184) in Honduras, registered as an OTC drug manufacturer, following a review of records requested under section 704(a)(4) of the FD&C Act. The letter, dated September 15, 2021, identifies significant CGMP violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** Failure to establish appropriate specifications for active ingredients (lidocaine hydrochloride and menthol) in GELAZUL Topical Analgesic and lack of testing for incoming menthol components.
2. **Insufficient Stability Testing Program (21 CFR 211.166(a)):** Lack of an adequate program to support the 3-year expiry of GELAZUL and hand sanitizer products, including quantitative assay determinations.
3. **Failure to Test Components (21 CFR 211.84(d)(2)):** Inadequate testing for impurities and identity of incoming components, specifically ethyl alcohol for Pharmaint Gel Hand Sanitizer.

Additionally, GELAZUL Topical Analgesic is cited as an unapproved new drug (21 U.S

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Carlos Barahona](https://www.keypedia.com/people/carlos-barahona/5cd441b8-ead1-4e08-8799-52d08cc133d2)
- [Compliance Officer](https://www.keypedia.com/people/matthew-r-dionne/cb73de54-3a7e-47c6-a7ba-a7e35e7e6c8d)

Company: https://www.keypedia.com/companies/laboratorio-pharma-international-srl/f42a5df2-4155-4acf-be8b-49a2aba24738

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