Drug factory · FDA FEI 1000113839
Browning's Pharmacy and Health Care Inc. DBA Browning's Health Care
141 E. Hibiscus Blvd., Melbourne, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 7, 2011.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2011: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Browning's Pharmacy and Health Care Inc. | 58755-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 7, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 7, 2011 inspection
- Examination of packaging and labeling 21 CFR 211.130(d)
Examination of packaging and labeling materials for suitability and correctness before packaging operations is not documented in the batch production records. - Expiration date lacking 21 CFR 211.137(a)
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Registered with FDA for: manufacture.