Dr. Reddy's Laboratories Ltd, CTO Unit 1
Form 483 issued May 5, 2023 · Sangareddy, India
- Inspection
- May 1 – May 5, 2023
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 1
- Pages
- 1
- FEI number
- 3002806851
In short: On May 5, 2023, FDA issued a Form 483 with 1 observation to Dr. Reddy's Laboratories Ltd, CTO Unit 1 in Sangareddy, Telangana (FEI 3002806851) after an inspection that ran May 1 – May 5, 2023. The investigator was Patty P. Kaewussdangkul. Most observations concern materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Components were not tested to ensure that storage conditions are appropriate to…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmDr. Reddy's Laboratories Ltd, CTO Unit 1 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories Ltd, CTO Unit 1?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories Ltd, CTO Unit 1?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of May 1 – May 5, 2023. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd, CTO Unit 1 inspected by FDA?
The inspection ran May 1 – May 5, 2023, and the Form 483 is dated May 5, 2023.
How do I get the full Form 483 for Dr. Reddy's Laboratories Ltd, CTO Unit 1?
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