Dr. Reddy's Laboratories Ltd.
Form 483 issued November 21, 2014 · Pydibhimavaram, India
- Inspection
- Nov 17 – Nov 21, 2014
- Investigators
- Carmelo Rosa· Dipesh K. Shah· Peter E. Baker
- Observations
- 9
- Pages
- 9
- FEI number
- 3002949085
In short: On November 21, 2014, FDA issued a Form 483 with 9 observations to Dr. Reddy's Laboratories Ltd. in Pydibhimavaram, Andhra Pradesh (FEI 3002949085) after an inspection that ran Nov 17 – Nov 21, 2014. The investigators were Carmelo Rosa, Dipesh K. Shah and Peter E. Baker. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.194 (2×) · 211.180 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory control records do not include complete data derived from all tests conducted to ensure compliance…
- 02
Computerized systems do not have sufficient controls to prevent unauthorized access or changes to data. There…
- 03
Batch production and control records do not include the weights and measures of components used in…
- 04
Procedures regarding the issuance, revision, superseding, and withdrawal of all…
This inspection in context
Carmelo Rosa
3 documents · 2001–2014
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmDr. Reddy's Laboratories Ltd. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories Ltd.?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories Ltd.?
Carmelo Rosa, Dipesh K. Shah and Peter E. Baker are named on this Form 483, for the inspection of Nov 17 – Nov 21, 2014. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd. inspected by FDA?
The inspection ran Nov 17 – Nov 21, 2014, and the Form 483 is dated November 21, 2014.
How do I get the full Form 483 for Dr. Reddy's Laboratories Ltd.?
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.