1 Dr. Reddy’s laboratories Louisiana, LLC
Form 483 issued November 10, 2015 · Shreveport, Louisiana
- Inspection
- Oct 20 – Nov 10, 2015
- Investigators
- Marvin D. Jones· Samantha J. Bradley
- Observations
- 8
- Pages
- 16
- FEI number
- 2311630
In short: On November 10, 2015, FDA issued a Form 483 with 8 observations to 1 Dr. Reddy’s laboratories Louisiana, LLC in Shreveport, Louisiana (FEI 2311630) after an inspection that ran Oct 20 – Nov 10, 2015. The investigators were Marvin D. Jones and Samantha J. Bradley. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
The firm1 Dr. Reddy’s laboratories Louisiana, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 1 Dr. Reddy’s laboratories Louisiana, LLC?
FDA listed 8 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected 1 Dr. Reddy’s laboratories Louisiana, LLC?
Marvin D. Jones and Samantha J. Bradley are named on this Form 483, for the inspection of Oct 20 – Nov 10, 2015. Each investigator has a profile showing what they cite most.
When was 1 Dr. Reddy’s laboratories Louisiana, LLC inspected by FDA?
The inspection ran Oct 20 – Nov 10, 2015, and the Form 483 is dated November 10, 2015.
How do I get the full Form 483 for 1 Dr. Reddy’s laboratories Louisiana, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.