Summary
High-impact items this period
Marquez Brothers International, Inc.
Undeclared milk allergen in food products
Why: Product contains milk not listed on label; allergen disclosure failure ·
Apr 29 ·
Impact: HIGH
B BRAUN MEDICAL INC
Sterility assurance failure in sterile water irrigation product
Why: Diaphragm port defect allows potential microbial contamination ·
Apr 29 ·
Impact: HIGH
B BRAUN MEDICAL INC
Sterility loss and port leakage potential in irrigation saline
Why: Defective diaphragm seal enables contamination pathway ·
Apr 29 ·
Impact: HIGH
Teva Pharmaceuticals USA, Inc
Tretinoin impurity exceeds specification in oral formulation
Why: Out-of-specification degradation impurity detected in product ·
Apr 29 ·
Impact: HIGH
B BRAUN MEDICAL INC
Sterility deficiency and diaphragm leakage in irrigation solution
Why: Manufacturing defect allowing contamination via compromised port seal ·
Apr 29 ·
Impact: HIGH
Leading Pharma, LLC
N-nitroso impurity in furosemide exceeds safety limits
Why: Genotoxic impurity contamination above recommended intake limit ·
Apr 29 ·
Impact: HIGH
B BRAUN MEDICAL INC
Sterility assurance failure and diaphragm port leakage risk
Why: Manufacturing defect enabling potential contamination via port leakage ·
Apr 29 ·
Impact: HIGH
Harrow Eye LLC
Sterility assurance deficiency in ophthalmic product lots
Why: Failed to demonstrate adequate sterilization process control ·
Apr 29 ·
Impact: HIGH
The Harvard Drug Group LLC
Capsule shell moisture specification failure during stability
Why: Out-of-spec loss on drying results in routine stability testing ·
Apr 29 ·
Impact: HIGH
Marquez Brothers International, Inc.
Undeclared milk allergen in food products
Why: Product contains milk not listed on label; allergen disclosure failure ·
Apr 29 ·
Impact: HIGH
Selected medium-impact items
Mondelez Global Llc
Hard corn starch lumps contamination in product
Why: Foreign material found during production or quality control process ·
Apr 29 ·
Impact: MEDIUM
Hetero Labs Limited (Unit V)
Tablet discoloration and visual defects in pantoprazole product
Why: Appearance defects with darker color and light spots reported ·
Apr 29 ·
Impact: MEDIUM
Premier Dental Products Co
Expiration date printing error on individual vials
Why: Transcription error resulted in extra digit on vial label only ·
Apr 29 ·
Impact: MEDIUM
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Manufacturing facility quality observations during FDA inspection
Why: FDA inspection on August 15, 2025 identified observations affecting product quality ·
Apr 22 ·
Impact: MEDIUM
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Manufacturing facility quality observations during FDA inspection
Why: FDA inspection on August 15, 2025 identified observations affecting product quality ·
Apr 22 ·
Impact: MEDIUM
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Data sourced from public government APIs. AI analysis via Claude Haiku.
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