Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

ARA-290 Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

PT-141 Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

LL-37 Injection (FarmaKeio) – Sterility Concerns (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Kill 'Dat Hand Sanitizer (Lula Holdings) – Acetaldehyde Excess (2022)

CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.

Class IIModerate

FDAApr 5, 2022LA• Lula Holdings L.L.C.

BPC-157 Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Trulicity Injection (Cardinal) – Temperature Abuse (2022)

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions

Class IIModerate

FDAApr 5, 2022NM• Cardinal Health Inc.

Melanotan II Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Ipamorelin/Sermorelin Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

NAD+ Nicotinamide Dinucleotide (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

T-101 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

SB-6 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

Phenylephrine Solution (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

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