FDA Inspection
DLP Twin County Regional Healthcare, LLCDLP Twin County Regional Healthcare, LLC – FDA Inspection, May 13, 2013
Record Details
This FDA Inspection record concerns DLP Twin County Regional Healthcare, LLC, with an inspection on May 13, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 13, 2013
- Product Type
- Biologics
View Company Profile
ID · 80751dd6-2ed0-4174-a83e-bca5dc66842b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 834823
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
10- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 640.3(a)Donor suitability not performed on day of collection
- 21 CFR 606.160(b)(6)Required records - transfusion reaction and complaints
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.121(c)(8)Caution statement - transfusion
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DLP Twin County Regional Healthcare, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 29, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for DLP Twin County Regional Healthcare, LLC
- FDA Inspection 715372 - 2011-03-21
- FDA Inspection 585928 - 2009-05-29
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.