Pharmatech LLC FDA Inspection Record
Pharmatech LLC is an FDA-inspected facility (FEI 3008328782) located in Davie, FL, US. RegDataLab tracks 4 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- May 2, 2017: Official Action Indicated (OAI)
- Inspections on record
- 4 (2 OAI, 1 VAI, 1 NAI)
- Last OAI inspection
- May 2, 2017
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 5, latest Aug 16, 2017
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 2, 2017 | Official Action Indicated (OAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Written procedures not established/followed (21 CFR 211.67(b)) Absence of Written Procedures (21 CFR 211.100(a)) Fill, assemble, package, label - quality (21 CFR 111.415) and 6 more |
| Aug 9, 2016 | Official Action Indicated (OAI) | Equipment Design, Size and Location (21 CFR 211.63) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Procedures for non-sterile drug products (21 CFR 211.113(a)) Product complaint - quality control investigate (21 CFR 111.560(a)(2)) and 4 more |
| Mar 2, 2016 | No Action Indicated (NAI) | No citations listed |
| Jan 24, 2012 | Voluntary Action Indicated (VAI) | Computer control of master formula records (21 CFR 211.68(b)) Equipment - automated - controls, process changes (21 CFR 111.30(d)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Aug 16, 2017 | Class II | D-0224-2018 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473… and 3 more products Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination |
| Aug 16, 2017 | Class II | F-0620-2018 | Rugby Liquid Vitamin C Supplement 500 mg 118 mL UPC 00536-0160-97 and 16 more products Presence of yeast and potential contamination with B. cepacia. |
| Aug 8, 2016 | Class II | D-1520-2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore… and 6 more products CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. |
| Aug 8, 2016 | Class II | F-0254-2017 | Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement. and 22 more products Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. |
| Mar 9, 2015 | Class II | F-2405-2015 | Rugby Poly Vitamin Liquid, 50ml and 1 more product Packaging label does not match individual product labeling. Outside packaging may have incorrect Lot/Exp and product identity. |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Pharmatech LLC
- Location
- Davie, FL (US)
- Source
- inspections