FDA Inspection 565081 — Woodhaven Pharmacy Services, LLC
The FDA completed an inspection of Woodhaven Pharmacy Services, LLC on Mar 19, 2009 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 41 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 19, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 1999 | 21 CFR 211.184(a) | Record information required |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3551 | 21 CFR 211.46(d) | Penicillin air handling systems not kept separate |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |