Maitland Labs of Central Florida

Warning LetterOpen

United StatesFEI 3013854204Issued Aug 6, 2021Office of Pharmaceutical Quality Operations, Division II

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013854204.

Violations0

Issue DateAug 6, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Maitland Labs of Central Florida
Location: United States
FEI Number: 3013854204
Country: United States
Issue Date: August 06, 2021
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Drugs
Status: Open

Summary

Based on limited metadata, Maitland Labs of Central Florida, a compounding pharmacy, received an FDA Warning Letter on August 6, 2021, regarding the production of adulterated drug products. The violations fall under pharmaceutical quality oversight and suggest issues with the compounding process, ingredient quality, or product safety standards. The warning was issued by the Office of Pharmaceutical Quality Operations, Division II, indicating the FDA's concern about systemic quality control deficiencies in the company's drug manufacturing practices.

Maitland Labs of Central Florida FDA Warning Letter, August 6, 2021