FDA Inspection
Puerto Rico Beverage IncPuerto Rico Beverage Inc – FDA Inspection, Sep 28, 2009
Record Details
This FDA Inspection record concerns Puerto Rico Beverage Inc, with an inspection on September 28, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Puerto Rico Beverage Inc
- Inspection Date
- September 28, 2009
- Product Type
- Drugs
View Company Profile
ID · 7d688e58-a7ea-47c9-94df-2a9f76556dc2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 618309
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 110.35(c)Lack of effective pest exclusion
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 110.40(e)Lack of thermometer
- 21 CFR 110.37(e)(5)Signs
- 21 CFR 211.198(a)Procedures to be written and followed
Showing 10 of 16 citations.
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.