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# CGMP Violations at Laboratorio Pharma International
- URL: https://www.fdaweb.com/cgmp-violations-at-laboratorio-pharma-international/
- Published: 2021-09-22T12:00:00.000Z
- Updated: 2026-09-14T17:15:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150196

FDA says its review of materials submitted by Laboratorio Pharma Internation SRL, Tegucigalpa, Honduras, a manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/laboratorio-pharma-international-srl-614766-09152021?ref=fdaweb.com) also says the firm’s Gelazul topical analgesic is a misbranded unapproved new drug. Specific CGMP violations are: 

- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine the appropriate storage conditions and expiration dates; and
- failing to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality.

The letter also explains the claims made for Gelazul that define it as an unapproved new drug and the reasons why it is misbranded.

FDA says the records the company provided indicate that it manufactures “potent compounds such as beta-lactams at your facility in addition to other finished drug products. In response to multiple requests that you clarify beta-lactam production controls, the records provided in each of your responses do not assure complete and comprehensive separation was established between beta-lactam and non-beta-lactam production.”

Laboratorio Pharma was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.